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Us Fda Jobs (NOW HIRING)

Freseniusglobal

Sr Manager, GxP Compliance Officer

OR · Remote

$172K - $180K/yr

This position organizes and promotes company-wide US-FDA quality and compliance improvement and compliance improvement efforts. Salary Range: $172,000-$180,000 Based on experience brought to the team ...

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US|R&D Sr Specialist|Contractor

Valhalla, NY · On-site

... US FDA regulations, as well as support updates to legacy label information documentation. This helps to ensure the accuracy of the regulatory information in our databases and on final artwork. The ...

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As of Jun 12, 2026, the average hourly pay for us fda in the United States is $38.43, according to ZipRecruiter salary data. Most workers in this role earn between $22.12 and $49.52 per hour, depending on experience, location, and employer.

What is the highest paying job at the FDA?

The highest paying jobs at the FDA are typically senior leadership roles such as the Commissioner of Food and Drugs or Deputy Commissioner, which can have salaries exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and often involve overseeing regulatory policies and organizational management.

Is it hard to get a job at FDA?

Getting a job at the FDA can be competitive due to high standards and rigorous hiring processes, which often include detailed applications, exams, and background checks. Candidates typically need relevant education, experience, and sometimes security clearances, making the process challenging but achievable with proper preparation.

What is the difference between Us Fda vs Us Pharmacist?

AspectUs FdaUs Pharmacist
Required CredentialsRegulatory knowledge, possibly a degree in health sciencesDoctor of Pharmacy (PharmD), state licensure
Work EnvironmentRegulatory agencies, laboratories, compliance officesPharmacies, hospitals, clinics
Industry UsageRegulatory oversight, policy developmentPatient care, medication dispensing
Common Search/ComparisonRegulatory roles, compliance jobsClinical roles, medication management

The main difference is that Us Fda professionals focus on regulation, compliance, and policy within the healthcare industry, often working for government agencies. In contrast, Us Pharmacists are healthcare providers directly involved in patient care and medication dispensing. While both roles require healthcare knowledge, their work environments and responsibilities differ significantly.

What are some common challenges faced by professionals working in roles related to the US FDA?

Professionals working in roles related to the US FDA often encounter challenges such as staying updated with frequently changing regulations and ensuring strict compliance with all applicable guidelines. They may also face tight deadlines when preparing documentation for product submissions or responding to regulatory inquiries. Collaboration across multidisciplinary teams—including legal, scientific, and quality assurance departments—is essential, which can require strong communication and project management skills. Navigating complex processes and balancing regulatory requirements with business needs are key aspects of the role.

What is the US FDA and what does it do?

The US FDA, or United States Food and Drug Administration, is a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation. The FDA regulates and oversees the approval of new drugs and medical devices, monitors food safety, and enforces regulations to ensure products meet safety standards. The agency also provides guidance to industry and the public on issues related to health and safety.

What qualifications do I need for FDA jobs?

FDA jobs often require a bachelor's degree in a relevant field such as biology, chemistry, or health sciences, along with relevant work experience. Some positions may require specialized certifications or advanced degrees, and strong analytical, communication, and regulatory knowledge are important for success in these roles.

Is FDA on a hiring freeze?

The U.S. Food and Drug Administration (FDA) periodically adjusts its hiring based on federal budget allocations and operational needs. As of now, there is no publicly announced nationwide hiring freeze, but hiring may be limited or prioritized depending on agency priorities and funding levels. Job seekers should monitor official FDA announcements and USAJOBS for current opportunities and updates.

What are the key skills and qualifications needed to thrive as a US FDA Regulatory Affairs Specialist, and why are they important?

To thrive as a US FDA Regulatory Affairs Specialist, you need in-depth knowledge of FDA regulations, strong analytical skills, and a degree in life sciences or a related field. Familiarity with regulatory submission platforms like eCTD, and certifications such as RAC (Regulatory Affairs Certification), are highly valuable. Exceptional attention to detail, problem-solving abilities, and strong written and verbal communication skills help professionals excel in this role. These skills ensure compliance with complex regulations, effective communication with regulatory agencies, and successful product approvals.
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Us Fda jobs near you

Sr Manager, GxP Compliance Officer

Fresenius Kabi

Lake Zurich, IL • On-site

$172K - $180K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 12 days ago

Fresenius Kabi rating

8.3

Company rating: 8.3 out of 10

Based on 41 frontline employees who took The Breakroom Quiz

23rd of 71 rated pharmaceutical

Job description

Job Summary
The Sr. Manager, GxP Compliance Officer (GCO) assures that all manufacturing sites and R&D Centers having activities with US-FDA are in compliance with US-FDA regulations, including but not limited to, cGMPs, cGLPs, and electronic records. This includes global facilities within Fresenius Kabi for importation of API or finished products to the US market. This position organizes and promotes company-wide US-FDA quality and compliance improvement and compliance improvement efforts.
Salary Range: $172,000-$180,000 Based on experience brought to the team
• Position is eligible to participate in a bonus plan with a target of 14% of the base salary (include only if applicable to the grade level)
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
Fully Remote Opportunity
Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.
Responsibilities
  • Responsible for leading, coordination, verification and tracking of global compliance activities within the pharmaceutical division
  • Evaluation of Investigations and Changes that could have an impact on regulatory commitments
  • Identification and remediation of plant quality and compliance risks through evaluation of tradition and non-tradition metrics, audit results, gap assessments, etc
    • Support plant on strategy and compliance plans for identified gaps
    • Lead/manage working groups to ensure mitigation plans are executed
  • Responsible for specific preparation of manufacturing sites and I&D Centers for upcoming US-FDA inspections, including but not limited to:
    • Training of plant staff for general inspection aspects and behaviors, as well as specific training for subject matter experts
    • Performance of mock inspections to evaluate the plants readiness for FDA inspection
    • Design and deliver need-based training to specific plants in response to identified gaps
  • Direct participation and support during US-FDA inspections (inspection room and back office), including:
    • Immediate guidance and support during inspections
    • Support and guidance in preparing response to FDA-483 observations
    • Independent review of Effectiveness of assigned FDA-483 CAPA
    • May also include inspections by local authorities when related to Mutual Recognition agreements
  • Responsible for identification of new FDA cGMP trends and development of strategies to fulfill new expectations
  • Strategic optimization and harmonization of cGMP and quality related processes to continuously improve pharmaceutical quality and compliance of Fresenius Kabi products
  • Preparation of global quality management documents (e.g. SOPs, guiding documents, working instructions)
  • Contribution, execution and management of global projects
  • Collaborate with other corporate quality functions on the execution of strategic goals
  • Communicate findings and risks to plant management as well as senior quality management
  • All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements
  • Minimum of Bachelor's degree required. Advanced degree in chemistry, molecular biology, microbiology or engineering field is highly desirable.
  • Accomplished US-FDA compliance expert.
  • Experience: 8+ years including practical experience in pharmaceutical industry and/or US-FDA.
  • A thorough knowledge of drug transfer processes, manufacturing processes for aseptically filled, terminally sterilized and lyophilized pharmaceuticals, cGMPs, ICH guidelines, regulatory compliance.
  • Professional experience in pharmaceutical industry, including technological understanding of manufacturing pharmaceuticals and combination products, aseptic processes, validation and qualification, risk management, root cause analysis and investigation management is required to be successful in this position.
  • Previous experience in executing and/or managing GxP audits or inspections a preferred
  • Ability to effectively interact with and influence plant personal and leadership regulators, global partners or affiliates, industry executives, trade organizations.
  • Established contacts to US-FDA are beneficial
  • Strong analytical problem-solving experience is essential. Demonstrated prior experience in leading and motivating teams to conceptualize and develop innovative and creative solutions that are robust and sustainable.
  • Ability to manage multiple complex situations, where precedent may not have been established. Ambiguity and uncertainty will often be associated within the framework of decision making facing this individual.
  • Ability to travel frequently (both domestically and internationally) is required.
  • Project Management, working in a Quality Management System and strong communication skills are required for this position.
  • Bilingual English/Spanish preferred

Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

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